VK100 Percutaneous Vertebral Augmentation System

VK100 Percutaneous Vertebral Augmentation System is an FDA 510(k)-cleared medical device (K192403) manufactured by Bonwrx, Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 7, 2019. Regulation: 8.